SODIUM ACETATE INJECTION USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SODIUM ACETATE

Disponibil de la:

OMEGA LABORATORIES LIMITED

Codul ATC:

B05XA08

INN (nume internaţional):

SODIUM ACETATE

Dozare:

328MG

Forma farmaceutică:

SOLUTION

Compoziție:

SODIUM ACETATE 328MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

REPLACEMENT PREPARATIONS

Rezumat produs:

Active ingredient group (AIG) number: 0113986001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1999-09-01

Caracteristicilor produsului

PRESCRIBING INFORMATION
SODIUM ACETATE INJECTION USP
Electrolyte Replenisher
328 mg / mL, 32.8%
For I.V. Infusion Only
Must be Diluted Before Use - Single Use Vial
DESCRIPTION
Sodium Acetate Injection USP is a sterile, nonpyrogenic, concentrated
solution of sodium acetate in Water
for Injection. The solution is administered after dilution by
intravenous route as an electrolyte replenisher.
It must not be administered undiluted.
The solution is intended as an alternative to sodium chloride to
provide sodium ion for addition to large
volume infusion fluids for intravenous use.
Sodium acetate anhydrous is chemically designated CH
3
COONa, a hygroscopic powder very soluble in
water.
CLINICAL PHARMACOLOGY
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of total cations at its normal
plasma concentration of approximately 140 mEq / L. The sodium ion
exerts a primary role in controlling
total body water and its distribution.
Acetate, a source of hydrogen ion acceptors, is an alternate source of
bicarbonate by metabolic conversion
in the liver. This has been shown to proceed readily, even in the
presence of severe liver disease.
INDICATIONS AND USAGE
Sodium Acetate Injection USP is indicated as a source of sodium, for
addition to large volume intravenous
fluids to prevent or correct hyponatremia in patients with restricted
or no oral intake. It is also useful as an
additive for preparing specific intravenous fluid formulas when the
needs of the patient cannot be met by
standard electrolyte or nutrient solutions.
CONTRAINDICATIONS
Sodium Acetate Injection USP is contraindicated in patients with
hypernatremia or fluid retention.
WARNINGS
Sodium Acetate Injection USP must be diluted before use. To avoid
sodium overload and water retention,
infuse sodium-containing solutions slowly.
Solutions containing sodium ions should be used with great care, if at
all, in patients with congestive heart
failure, severe renal insufficiency, and in clinical states in which
there exists edema with sodium ret